Preview Newsletter
Ethicon Media Monitoring 3/17/2017
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Plaintiffs Petition for Hernia Mesh Lawsuit Consolidation in Florida
Mar 16, 2017 | Drugwatch
By Michelle Llamas
Plaintiffs who say Ethicon’s Physiomesh Composite hernia mesh left them with serious injuries petitioned the court to consolidate lawsuits in Florida. -
Pelvic mesh left a man 'stabbed' during sex, regulator warned
Mar 17, 2017 | Newcastle Herald
By Joanne McCarthy
ANDREA Walter is the woman whose former husband’s penis was “stabbed” while they were having sex, after mesh implanted in her body to treat incontinence eroded through her vaginal wall in 2012. -
Australian Investigation into Transvaginal Mesh Leads to Trials and Senate Inquiry
Mar 17, 2017 | Mesh Medical Device Newsdesk
Unlike the U.S. media, Australian media is reporting on its transvaginal mesh debacle with citizens leading the charge. -
Mesh implant review expert resigns
Mar 16, 2017 | Holyrood
By Tom Freeman
A consultant working on the independent review of mesh implants in Scotland has resigned, it has been reported.
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Plaintiffs Petition for Hernia Mesh Lawsuit Consolidation in Florida
Mar 16, 2017 | Drugwatch
By Michelle Llamas
Plaintiffs who say Ethicon’s Physiomesh Composite hernia mesh left them with serious injuries petitioned the court to consolidate lawsuits in Florida.
On March 9, 2017, plaintiffs filed a Motion for Transfer for 18 hernia mesh lawsuits filed in nine separate courts across the country: Florida, Illinois, Georgia, Colorado, South Carolina, Kentucky, Massachusetts, Oklahoma and New Jersey.
Doctors use Ethicon’s Physiomesh Composite mesh to repair hernias, areas of weak muscle in the abdomen. Injuries mentioned in lawsuits include infections, organ damage, autoimmune problems, adhesions (scar tissue) and bowel obstruction that require additional surgery.
The motion petitions the court to consolidate cases in multidistrict litigation (MDL). In the MDL process, the court groups cases with similar damages and allegations together under one federal judge to speed up litigation.
“All of the plaintiffs in the constituent cases claim that the devices implanted in their bodies were defectively designed and/or manufactured, and that the defendants failed to provide appropriate warnings and instructions regarding the dangers posed by these devices,” according to the motion.
Ethicon sold about 330,000 Physiomesh hernia mesh implants worldwide. It sold about 50 percent of those products in the U.S., according to plaintiffs. Ethicon voluntarily pulled the mesh from the market in May 2016 after it found higher rates of reoperation and hernia recurrence.Cases May be Consolidated in Florida or Illinois
The first choice for consolidation is the Middle District of Florida, where the most cases are currently pending. The Middle District of Florida also has the resources and is able to resolve cases quickly.
Florida judge Hon. Paul G. Byron is already handling one of the first hernia mesh lawsuits. He would be “well-suited to handle this litigation,” plaintiffs said.
Plaintiffs also recommended Judges James D. Whittemore and Susan C. Bucklew.
The second choice for consolidation is the Southern District of Illinois under Judge David R. Herndon who is presiding over two MDLs: Yasmin and Yaz (MDL 2100) and Pradaxa (MDL 2385).Lawyers Compare Hernia Mesh to Pelvic Mesh
Lawyers compared hernia mesh cases to transvaginal mesh lawsuits already consolidated in multiple MDLs under Judge Joseph R. Goodwin in West Virginia.
Hernia mesh is made of the same polypropylene plastic. As of March 15, 2017, there are more than 60,000 claims pending against six transvaginal mesh manufacturers. At one time, there were close to 100,000.
Plaintiffs in hernia mesh litigation suffer similar complications as transvaginal mesh victims.
“The plaintiffs herein suffered serious and often permanent physical injuries from the implantation of the Physiomesh, often requiring additional surgeries, additional medical expenses, and unresolved medical complications,” hernia mesh plaintiffs wrote in court documents.
Ethicon is not the only company facing hernia mesh lawsuits. C.R. Bard’s subsidiary Bard Davol faces litigation for its Kugel Hernia Patch. Maquet Getinge Group’s subsidiary Atrium Medical Corp. faces lawsuits over its C-QUR line of surgical mesh.
https://www.drugwatch.com/2017/03/16/petition-hernia-mesh-lawsuit-consolidation-florida/
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Pelvic mesh left a man 'stabbed' during sex, regulator warned
Mar 17, 2017 | Newcastle Herald
By Joanne McCarthy
ANDREA Walter is the woman whose former husband’s penis was “stabbed” while they were having sex, after mesh implanted in her body to treat incontinence eroded through her vaginal wall in 2012.
It happened six weeks after the surgery, and it happened again before her doctor twice trimmed the mesh that moved from inside her body into her vagina.
In a complaint in 2013 to the health regulator that cleared at least 88 mesh devices for use in Australia, the Therapeutic Goods Administration, Ms Walter said her husband was “stabbed numerous times”, until she had further surgery where the doctor stitched some of her vaginal wall over two areas where mesh protruded.
“So far, these areas haven't eroded back through my vagina, and my husband is no longer being stabbed when having sex,” Ms Walter said in her 2013 complaint.
By 2014 she had the mesh removed after a succession of problems including increased incontinence, bleeding and pain, and concern that her mesh would erode into her urethra and bladder.
In her complaint Ms Walter said she had the mesh implanted during a hysterectomy. She told the TGA her doctor said it was “a quick 10-20 minute procedure, that he could combine with the hysterectomy”.
“He said that complications were rare, and the TVT was very straightforward, with a very high rate of success,” she wrote.
She was implanted with Johnson & Johnson Gynecare TVT Exact mesh, and is one of 450 women in a class action run by Shine Lawyers against the company that will start in July.
So far, these areas haven't eroded back through my vagina, and my husband is no longer being stabbed when having sex.- Mesh victim Andrea Walter
“I liken the mesh to the blue tape that’s used around boxes if you get a fridge or something large like that. My doctor gave me some of the tape to feel before the operation. I didn’t understand how it went into me but it didn’t sound like it was an issue,” Ms Walter said.
“There was no talk that it could be causing my pain that was in my groin and legs, or that there could be a potential penis-severing incident.”
She said her husband swore when it first happened, but they thought the cause was sutures after the surgery.
he described her mesh as “like a ticking time bomb”, where “your body has something in it that it doesn’t want”. She cannot work full time and suffers permanent and long term complications.
A Senate inquiry will consider how mesh was cleared for use in Australia after the TGA cancelled 88 mesh devices because of lack of clinical evidence.
In a statement in August the TGA said complications were “most likely under-reported” and some patients may not realise their symptoms are mesh-related.
In a list of 30 possible complications or adverse events after mesh surgery, quietly released by the TGA in August after a meeting with members of the Australian Pelvic Mesh Support Group, it included mesh extrusion, exposure or erosion into the vagina or other structures or organs; a foreign body response; punctures or lacerations of vessels, nerves, structures or organs including the bladder, urethra or bowel.
Mesh complications could also include acute and chronic pain, pain during intercourse, neuromuscular problems including pain in the groin, thigh, leg, pelvic and abdominal area, recurrence of incontinence and vaginal discharge.
The TGA also noted that “exposed mesh may cause pain or discomfort to the patient’s partner during intercourse”.
http://www.theherald.com.au/story/4535453/mesh-in-stabbing-incident/
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Australian Investigation into Transvaginal Mesh Leads to Trials and Senate Inquiry
Mar 17, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, March 16, 2017 ~ Unlike the U.S. media, Australian media is reporting on its transvaginal mesh debacle with citizens leading the charge.
Transvaginal mesh devices seem to be front page news overseas.
Joanne McCarthy writes for the Newcastle Herald, located about 100 miles north of Sydney, Australia. The paper is in the midst of a series of aggressive investigative reports on the gaps in Australia’s health regulatory systems.
That has helped galvanize the efforts of the Australian Pelvic Mesh Support Group and bring forward the voice of the injured. The reports have also highlighted the huge gaps in any safety net to assure patient safety.
An estimated 100,000 women in Australia have been implanted with transvaginal mesh. More than 40 mesh devices for prolapse surgery were eventually cleared for use in Australia.
The Australian process for medical device approval mirrors that established by the U.S. Food and Drug Administration (FDA), that is cleared for marketing with no clinical evidence supporting safety and efficacy.
As a result of the publicity and patient activism, Australia is taking some action.
The Australian Pelvic Mesh Support Group initiated a Senate inquiry into the mesh scandal in Australia. It is taking submissions until May 31 and a public hearing will take place mid-year with a report expected in November.
On July 4, 2017, Shine Law in Australia is representing about 450 women in a class action against Johnson & Johnson which could run up to six months.
It will be one of the largest medical civil actions in Australia.
A second class action involving 300 Australian women will be launched against American Medical Systems, maker of the Perigee and Apogee.
McCarthy’s Reports Include:
“Transvaginal mesh devices have left many women with permanent injuries.”3/14/17
A 2013 paper titled “The Transvaginal Mesh Decade” was written by Associate Professor Chris Maher. He blames the U.S. Food and Drug Administration and regulators in Australia for clearing transvaginal mesh devices without evidence of safety and efficacy.“Pelvic mesh victim in the dark about mesh implant for nearly a decade” (here) 3/15/17
Lynda Garling didn’t even know she had been implanted with transvaginal mesh in 2004. She lost her business after being treated for a cluster of symptoms and pain. Here is a video that accompanies the story. Lynn Garling said “I feel like I’d been raped.”“Dr. Peter Petros said he warned women about the ‘very frightening’ symptoms of his procedure” 3/15/17
In a 2004 court action in Western Australia Dr. Peter Petros, who brought one mesh to Australia, testified that women could experience a disgusting yellow discharge following an implant. That was “how the operation works” was offered as an explanation. The 45-year-old woman, who sued him, was awarded more than $136,000 as compensation.Dr. Petros performed the first prototype IVS operation in Perth and in 1990 he filed for the IVS-Tunneller patent. Dr. Petros collaborated with the late Dr. Ulf Ulmsten to develop the midline IVS operation. He was compensate $15 per instrument of the IVS Tunneller he performed at about 400 per year, according to the inquiry. The story outlines his attitude toward the pelvic surgery and its associated complications.
In Australia just one company, the Adelaide firm TFS Manufacturing sold more than 15,700 devices from 2006. In November, 2014 TFS became one of the first mesh devices in the world to be deregistered after failing to provide evidence of its safety.
“Newcastle doctor and Queensland colleague sounded alarm on mesh in 2003” 3/14/17
Two doctors who wrote a paper in 2003 sounding the alarm about pelvic mesh procedures after treating women injured by the products seen in Germany and Switzerland as well as Australia.RADIO
The publicity is not limited to print. Radio show 2HD Radio Newcastle has broadcast two high profile interviews.A radio host calls the mesh debacle, “The biggest medical scandal since Thalidomide.” 2HD Radio Newcastle interviewed the founder of the Australian Mesh Support Group founder Caz Chisholm. Chisholm had her mesh removal in St. Louis by Dr. Veronikis.
Senator Derryn Hinch is interviewed (here) by 2 HDRadio says because the word “transvaginal”, the media won’t touch it. Here is his testimony to the Senate, The Age newspaper, Women are, “kept in the dark like mushrooms, fed bullshit.”
The Newcastle Herald Inquiry
The newspaper finds the IVS Tunneller was tested on 13 large dogs in Western Australia in 1987. It became the first transvaginal mesh used in Australia beginning in 2001.
Associate Professor Chris Maher blames regulators in the U.S. as well as his country. The IVS Tunneller was cleared by the FDA in 2001 to treat prolapse in women. Using the 510(k) substantially equivalent standard it served as a predicate for a proliferation of prolapse mesh devices for the next decade.
Referring to the period from the 1980s to the 1990s, any safety measures suffered a system failure he says in his 2013 report, The Transvaginal Mesh Decade.
While regulators were asleep, doctors provided an even bigger gap in the safety net.
Instead of protecting patients, doctors were ready and willing to hear the “aggressive marketing” messages from manufacturers and were largely silent. Surgical techniques were taught and developed by the manufacturers of the products and the lessons disseminated by key opinion leaders.
The ever-widening hole in any safety net is blamed on Australia’s version of the FDA, the Therapeutic Goods Administration (TGA). It was not able to share the percentage of women suffering adverse events after their mesh surgery.
The second mesh device used in Australia was the Tension-free Vaginal Tape or TVT, which resulted from a collaboration between Dr. Peter Petros and the late Dr. Ulf Ulmsten of Sweden, who developed TVT and sold it to Johnson & Johnson.
The TGA estimates it only receives 10% to 20% of all complication reports associated with mesh, largely because surgeons are not aware of that country’s adverse event reporting systems. ###
LEARN MORE:
Here is the 510(k) FDA Summary of the Covidien IVS Tunneller
https://www.accessdata.fda.gov/cdrh_docs/pdf7/K073164.pdfIVS Tunneller trademark details
https://trademarks.justia.com/773/21/ivs-77321440.htmlHistory of IVS Tunneller
http://www.laparoscopy.ru/article/ivs.htmlKorean J of Urology Mar 2006 IVS for patients
https://www.icurology.org/search.php?where=aview&id=10.4111/kju.2006.47.3.263&code=1020KJU&vmode=PUBREADERMaher writes about this in his 2013 paper titled “The Transvaginal Mesh Decade.”
https://www.parliament.nz/resource/mi-nz/50SCHE_EVI_50DBHOH_PET3197_1_A400626/98a708b5cc688bea76ab93ae3ab6a670cf58153eMesh News Desk, August 2016 ~ TGA Urges women to report Mesh Adverse Events,
http://www.meshmedicaldevicenewsdesk.com/australia-wants-report-mesh-adverse-events/Mesh News Desk, October 15, 2012 ~ Australia’s Vaginal Mesh- Largest Class Action in History?
http://www.meshmedicaldevicenewsdesk.com/australias-vaginal-mesh-largest-class-action-in-history/Mesh News Desk, March 6, 2012 ~ Australia’s Version of FDA Lax on Medical Device Safety
http://www.meshmedicaldevicenewsdesk.com/australias-vaginal-mesh-largest-class-action-in-history/Mesh News Desk, July 12, 2016 ~ Mesh Mess- Banner Pelvic Mesh receives New Life as a Breast Lift
http://www.meshmedicaldevicenewsdesk.com/mesh-mess-banned-pelvic-mesh-receives-new-life-breast-lift/TFS tissue fixation system made by TFS Surgical of Adelaide Australia, created by Dr. Petros in collaboration with the late Dr. Ulf IUlmsten, MD.
http://www.meshmedicaldevicenewsdesk.com/mesh-mess-banned-pelvic-mesh-receives-new-life-breast-lift/http://www.meshmedicaldevicenewsdesk.com/australian-investigation-transvaginal-mesh-leads-trials-senate-inquiry/
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Mesh implant review expert resigns
Mar 16, 2017 | Holyrood
By Tom Freeman
A consultant working on the independent review of mesh implants in Scotland has resigned, it has been reported.
According to the BBC the expert has quit after claims an entire chapter of the review's report has been removed.
The altering of the final report was also cited as the reason for the resignation of two patients from the group.
The two women who had suffered severe complications with mesh implant surgery said the forthcoming report has been altered and watered down since the interim report in 2015.
The group's chair Public Health expert Dr Lesley Wilkie stood down in December.
Transvaginal mesh implants are medical devices used to treat organ prolapse and incontinence in women.
Over 20,000 women have had similar implants in Scotland, with around 400 currently taking legal action against health boards and mesh implant manufacturers after experiencing severe complications.
Health Secretary Shona Robison said she wanted survivors to remain at the centre of ongoing work.
"I have been clear that all evidence must be made publically available alongside the report once published. The chair of the Review Group has stressed to me the evidence has been fully considered by the review and none has been hidden.
"This is a complex, technical area and on occasions professionals will disagree. I am aware of the resignation of a clinical member from the group and, while this is unfortunate, their views and contribution to the review is much-appreciated and have proven valuable."
Labour MSP Neil Findlay, who chairs the Health and Sport Committee, called on Robison to update parliament on what he described as "a whitewash".
"The mesh scandal is a global scandal but in Scotland we had the chance to lead the world in protecting women from life changing injuries but instead of doing so the Government stands by as the review draft is rewritten and all the while more and more people lodge damages claims against our NHS," he said.
https://www.holyrood.com/articles/news/mesh-implant-review-expert-resigns
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